Trial Radar IA | ||
|---|---|---|
Lo studio clinico NCT07325981 per Paralisi cerebrale è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
Un studio corrisponde ai criteri del filtro
Vista a schede
Effect of Biofeedback-Enhanced Exergaming, Exergaming Alone, and Traditional Physical Therapy on Motor Function, Adherence, and Engagement in Children With Cerebral Palsy: A RCT 90 Randomizzato Pediatrico
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07325981 è uno studio interventistico per Paralisi cerebrale, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 15 dicembre 2025, con l'obiettivo di raggiungere 90 partecipanti. Sotto la guida di Ziauddin University, dovrebbe concludersi entro il 1 agosto 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 8 gennaio 2026.
Sommario breve
Cerebral Palsy (CP) accounts for approximately 0.9% of the global disease burden and affects 2.4-4% of children under 5 years old, with associated developmental and coordination impairments. Pediatric physical therapy aims to enhance independence and quality of life; however, maintaining adherence to conventional treatment remains a major challenge due to its repetitive and monotonous nature, leading to reduced motiv...Mostra di più
Descrizione dettagliata
This single-blinded randomized controlled trial will be conducted at Ziauddin Hospital and the IHRI Rehabilitation Centre and School, Karachi, Pakistan. A total of 90 children (aged 6-12 years) with spastic diplegic or hemiplegic cerebral palsy (GMFCS levels I-II) will be recruited through purposive sampling and stratified by age band (6-8 vs. 9-12 years) and GMFCS level. Participants will be randomized (1:1:1) into ...Mostra di più
Titolo ufficiale
Effect of Biofeedback-Enhanced Exergaming, Exergaming Alone, and Traditional Physical Therapy on Motor Function, Adherence, and Engagement in Children With Cerebral Palsy (GMFCS I-II): A Randomized Controlled Trial
Patologie
Paralisi cerebraleAltri ID dello studio
- 11120925SIPT
Numero NCT
Data di inizio (effettiva)
2025-12-15
Ultimo aggiornamento pubblicato
2026-01-08
Data di completamento (stimata)
2026-08-01
Arruolamento (previsto)
90
Tipo di studio
Interventistico
FASE
N.D.
Stato
Non ancora in arruolamento
Parole chiave
cerebral palsy, exergaming, bio-feedback, GMFCS, traditional physical therapy
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Sperimentaleexergaming The exergaming program will use Kinect Adventures (River Rush, Reflex Ridge) to train balance, agility, and trunk control; Kinect Sports to improve lower-limb activation, hand-eye coordination, and bilateral movements; Just Dance Kids for rhythmic stepping; and Kinect Party/Happy Action Theater to encourage free movement. Optional MIRA Rehab modules may target posture and agility. Sessions will be held three times pe...Mostra di più | Exergaming The exergaming program will use Kinect Adventures (River Rush, Reflex Ridge) for balance and agility, Kinect Sports for lower-limb activation and coordination, Just Dance Kids for rhythmic stepping, and Kinect Party/Happy Action Theater for free movement. Optional MIRA Rehab modules may target posture and agility. Sessions will occur three times weekly for twelve weeks, beginning with a light warm-up, followed by 20-...Mostra di più |
Sperimentalebiofeedback-enhanced exergaming This group will perform the same exergaming activities as the exergaming group, with the added integration of real-time multimodal biofeedback to enhance motor learning. The frequency and duration of sessions will be identical to the exergaming group. Participants will receive on-screen visual guides that indicate whether their movements are being performed correctly, along with auditory feedback through performance-...Mostra di più | biofeedback-enhanced exergaming This group will perform the same exergames as Intervention 1 but with real-time visual, auditory, and optional vibration feedback to enhance motor learning. Surface EMG (Delsys Trigno) will record bilateral muscle activity, and Microsoft Kinect SDK (v2/Azure) will track joint motion and posture. Session frequency and duration will be identical. |
Comparatore attivotraditional physical therapy Children in this group will receive standard physical therapy to improve gross motor function, especially balance and mobility. Sessions will be held three times per week for twelve weeks, lasting 30-45 minutes. The protocol includes a 5-minute warm-up, 12-15 minutes of strengthening for hip, knee, and ankle muscles, 8-10 minutes of balance training using wobble boards or foam, and 8-10 minutes of functional mobility...Mostra di più | Terapia fisica tradizionale Children in this group will receive standard physical therapy to improve gross motor function, especially balance and mobility. Sessions will be held three times per week for twelve weeks, lasting 30-45 minutes. The protocol includes a 5-minute warm-up, 12-15 minutes of strengthening for hip, knee, and ankle muscles, 8-10 minutes of balance training using wobble boards or foam, and 8-10 minutes of functional mobility...Mostra di più |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Gross Motor Function Improvement | Outcome Measure Title:
Gross Motor Function Measure (GMFM-88) total score (%)
Description:
Gross motor function will be assessed using the Gross Motor Function Measure-88 (GMFM-88), a standardized observational tool evaluating motor skills across five domains: lying \& rolling, sitting, crawling \& kneeling, standing, and walking/running/jumping. Scores are expressed as a percentage of the maximum possible score.
Score range: 0-100% Interpretation: Higher scores indicate better gross motor function. | 4-6 months |
Balance Performance | Outcome Measure Title:
Pediatric Balance Scale (PBS) total score
Description:
Balance performance will be measured using the Pediatric Balance Scale (PBS), a functional balance assessment adapted from the Berg Balance Scale. The scale consists of 14 tasks assessing static and dynamic balance during functional activities.
Score range: 0-56 Interpretation: Higher scores indicate better balance performance. | 4-6 months |
Postural Control | Outcome Measure Title:
Postural stability parameters derived from Kinect-based motion analysis
Description:
Postural control stability will be quantified using Kinect-based motion tracking, capturing center of mass displacement, joint angles, and sway during task-based activities. Movement stability indices (e.g., reduced sway amplitude and improved alignment) will be derived from kinematic data.
Measurement units: Degrees (joint angles), millimeters (displacement), task-specific stability indices Interpretation: Lower sway and improved alignment indicate better postural stability. | 4-6 months |
Functional Mobility | Outcome Measure Title:
Timed Up and Go (TUG) test duration (seconds)
Description:
Functional mobility will be assessed using the Timed Up and Go (TUG) test, which measures the time required to stand from a seated position, walk 3 meters, turn, return, and sit down.
Score range: Continuous variable (seconds) Interpretation: Shorter completion times indicate better functional mobility. | 4-6 months |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Muscle Activation Patterns | Outcome Measure Title:
Surface electromyography (sEMG) amplitude and activation timing during task performance
Description:
Surface EMG will be used to record muscle activation amplitude and timing during functional tasks. Outcome variables will include normalized EMG amplitude and coordination patterns across target muscle groups.
Measurement units: Microvolts (µV), normalized activation ratios Interpretation: More efficient and coordinated activation patterns indicate improved motor control. | 4-6 months |
Game performance score | Score range: System-generated scores Interpretation: Higher game scores indicate improved motor learning and performance. | 4-6 months |
task completion time during virtual-based tasks | Description:
Motor learning including task completion time generated by the virtual rehabilitation system.
Interpretation: reduced completion times indicate improved motor learning and performance. | 4-6 months |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Bambino
Età minima
6 Years
Sessi idonei
Tutti
Diagnosed with Cerebral Palsy (CP), specifically spastic diplegia, spastic hemiplegia, or mild ataxia.
- Gross Motor Function Classification System (GMFCS) Level I or II.
- Male and female aged between 6 and 12 years at the time of enrollment.
- Manual Ability Classification System (MACS) Level I or II.
- Able to follow simple two-step commands, with or without augmentative and alternative communication (AAC).
- Demonstrates adequate cognitive functioning based on the NIH Toolbox Picture Sequence Memory Test (PSMT), scoring at or above the 25th percentile (T-score ≥ 40) based on age-adjusted norms.
- Hearing and vision adequate to participate in exergaming tasks (with or without assistive devices).
- Able to stand and participate in basic movements with or without minimal assistance.
- Willingness to participate and written informed consent from parent/guardian with assent from the child.
GMFCS Level III or higher, indicating significant gross motor limitations.
- MACS Level III or higher, indicating significant manual impairment.
- Severe uncorrected visual or hearing impairment that would interfere with interaction during exergaming.
- Uncontrolled epilepsy or other neurological condition contraindicating active movement.
- Significant behavioral or attention challenges that prevent engagement with game-based tasks.
- Score below the 25th percentile on the PSMT, indicating insufficient episodic memory to follow game tasks.
- Involvement in any other intervention trial that may interfere with study participation.
- Medical conditions that contraindicate participation in physical activity (as determined by a physician).
Ziauddin UniversityParte responsabile dello studio
Sajid Iqbal, Investigatore principale, Assistant Professor/Physical Therapist, Ziauddin University
Contatti principali dello studio
Contatto: Sajid Iqbal Khan, P.hD*, +923322380904, [email protected]
Contatto: Dr. Amna Aamir khan, P.hD., +92324249814, [email protected]
1 Centri dello studio in 1 paesi
Sindh
Ziauddin University, Karachi, Sindh, 75850, Pakistan
Associate Professor/ Post Graduate Director FAHS, PhD, Contatto, +92 324 2497814, [email protected]